The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Pre-powdered Non-sterile/sterile Vinyl Examination Gloves.
| Device ID | K962069 |
| 510k Number | K962069 |
| Device Name: | MEDLINE PRE-POWDERED NON-STERILE/STERILE VINYL EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Contact | Betty A Lock |
| Correspondent | Betty A Lock MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-28 |
| Decision Date | 1996-08-19 |